MAUDE Adverse Event Report: PALETTE LIFE SCIENCES SOLESTA INJECTABLE GEL; AGENT, BULKING, INJECTABLE F

Catalog Number	011506
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Constipation (3274)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, palette life sciences received a notification from the [physician] "[patient] 5 days post solesta injection experienced 2 days of low-grade fever and a feeling of fullness, constipation, and incomplete bowel emptying." the physician reported the patient has been taking magnesium and colace for constipation post-procedure.Multiple attempts for additional information have been requested from the complainant has been unsuccessful at the time of this report.The patient's condition is unknown.
Additional Manufacturer Narrative
Qn#(b)(4).Udi number unavailable as complainant did not report a lot number.Other remarks: n/a corrected data: n/a.
Event or Problem Description
On 01-jul-2024, palette life sciences received a notification from the [physician] "[patient] 5 days post solesta injection experienced 2 days of low-grade fever and a feeling of fullness, constipation, and incomplete bowel emptying.".The physician reported the patient has been taking magnesium and colace for constipation post-procedure.Multiple attempts for additional information have been requested from the complainant has been unsuccessful at the time of this report.The patient's condition is unknown.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review could not be conducted since the lot number of the device was not provided.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Palette life sciences will continue to monitor and trend for reports of this nature.Udi number unavailable as complainant did not report a lot number.Other remarks: n/a.Corrected data: n/a.

• Brand Name: SOLESTA INJECTABLE GEL
• Common Device Name: AGENT, BULKING, INJECTABLE F
• Manufacturer (Section D): PALETTE LIFE SCIENCES; santa barbara
• Manufacturer (Section G): PALETTE LIFE SCIENCES; 27 e cota st, suite 402; santa barbara
• Manufacturer Contact: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19706707
• Report Number: 3014909464-2024-00010
• Device Sequence Number: 20472428
• Product Code: LNM
• UDI-Device Identifier: 00850004725016
• UDI-Public: 00850004725016
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P100014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 011506
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown